Isitifiketi Sokuqinisekisa Ikhwalithi
Lo mbhalo uqinisekisa umkhiqizo owenziwe i-TS Filter ngokuhambisana nezindinganiso Zamanje Zomkhuba Wokukhiqiza Okuhle. Lo mkhiqizo uyathuthukiswa, ukhiqizwe futhi usatshalaliswe ngokuvumelana nesistimu yokuphatha egunyazwe yi-ISO9001:2018.
Imibandela Yokuqinisekisa Ikhwalithi
Inhlanzeko
Lo mkhiqizo wokuhlunga uthobela isihloko 21 CFR, isigaba 210.3 (b) (5) (6) kanye no-211.72
❖ TOC & Conductivity
Ngemuva kokushaywa kwamanzi okulawulwayo, amasampula anekhabhoni engaphansi kuka-0.5mg (500 ppb) ilitha, futhi ukuqhutshwa kwe-conductivity kungaphansi kuka-5.1 S/cm @ 25°c.
❖ Amagciwane Endotoxin
I-capsule ekhipha amanzi iqukethe ngaphansi kuka-0.25EU/ml
❖ Ukuphepha kwamagciwane
Zonke izinto zalesi sihlungi zihlangabezana nezimfuneko ze-USP<88> yamanje yesigaba sepulasitiki VI-121°c.
❖ Isengezo sokudla esingaqondile
Zonke izinto ezisetshenziswayo zihlangabezana nezidingo ze-FDA ezingaqondile zokungeza ukudla ezishiwo ku-21CFR. Zonke izinto ezisetshenziswayo zihlangabezana nemfuneko yomthethonqubo we-EU 1935/2004/EC. Xhumana nabahlinzeki ngolwazi oluthe xaxa mayelana nezinto zokwakha.
❖ Isitatimende Somsuka Wezilwane
Ngokusekelwe olwazini lwamanje oluvela kubahlinzeki bethu, yonke into esetshenziswa kulo mkhiqizo ayizilwane-mahhala.
❖ Ukugcinwa Kwamagciwane
Lo mkhiqizo uhlolelwe ngempumelelo ukugcinwa kwe-microorganism eyinselele eyamukelekayo, kusetshenziswa izinqubo ezichazwe Kumihlahlandlela Yokuqinisekisa Isihlungi se-TS futhi ehlotshaniswa ne-ASTM Standard Test Methos ASTM F838, ngokuhambisana nezidingo ezisebenzayo ze-FDA Guideline Sterile Drug Products Produced by Aseptic Processing- Umkhuba Wamanje Wokukhiqiza Okuhle (Septhemba 2004).
❖ Imibandela Yokukhishwa Kwenqwaba
Le ndawo yokukhiqiza yenziwa isampula, yahlolwa futhi yakhululwa yi-TS Filter Quality Assurance.
❖ Ukuhlolwa Kobuqotho
Isici ngasinye sokuhlunga sihlolwe isiqinisekiso sekhwalithi ye-TS Filter ngokusekelwe kumazinga angezansi, bese siyakhululwa.
Izinga Lokuhlola Ubuqotho (20°c):
Iphuzu lebhamuza (BP) , Ukugeleza Kokusabalalisa (DF)
Qaphela: I-BP ne-DF kufanele ihlolwe ngemva kokumanziswa kwesici sokuhlunga.
Kulesi sihlungi, lawa mazinga okuhlola ubuqotho ahlotshaniswe ngokugcwele nokuhlolwa kwe-ASTM F838 bacteria Challenge, ngokuvumelana nezimfuneko ezisebenzayo ze-FDA Guideline Sterile Drug Products Produced by Aseptic Processing-Current Good Manufacturing Practice (Julayi 2019).
❖ Ukuhlola Ukuvuza
Isici sokuhlunga ngasinye sihlolwe isiqinisekiso sekhwalithi ye-TS Filter ngokusekelwe Emazingeni angezansi, bese siyakhululwa: Akukho ukuvuza ku-0.40MPa phakathi nemizuzu engu-5.